NDC Code(s) : 67877-626-90, 67877-626-01, 67877-626-05, 67877-626-06
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ibuprofen and famotidine Ibuprofen and famotidine TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM) 		IBUPROFEN800 mg
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE26.6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SHELLAC(UNII: 46N107B71O)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color BLUE (light blue) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code IF826
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-626-9090 in 1 BOTTLE Type 0: Not a Combination Product08/04/2021
2NDC:67877-626-01100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2021
3NDC:67877-626-05500 in 1 BOTTLE Type 0: Not a Combination Product08/04/2021
4NDC:67877-626-066 in 1 CARTON 08/04/2021
41 in 1 BLISTER PACK Type 0: Not a Combination Product08/04/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211890 08/04/2021

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-626)

PRINCIPAL DISPLAY PANEL

NDC 67877-626-90
ATTENTION PHARMACIST: Dispense attached Medication Guide to each patients
Rx Only
90 Tablets
 ibuprofen-famotidine-90-tablets
NDC 67877-626-06
ATTENTION PHARMACIST: Dispense attached Medication Guide to each patients
Rx Only
6 Tablets (1X6 Unit -Dose)
 ibuprofen-famotidine-90-tablets
NDC 67877-626-06
6 Tablets (1X6 Unit -Dose)

Blister Label

 ibuprofen-famotidine-90-tablets